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• Background Little research has been conducted to validate pain assessment tools in critical care, especially for patients who cannot communicate verbally.
• Objective To validate the Critical-Care Pain Observation Tool.
• Methods A total of 105 cardiac surgery patients in the intensive care unit, recruited in a cardiology health center in Quebec, Canada, participated in the study. Following surgery, 33 of the 105 were evaluated while unconscious and intubated and 99 while conscious and intubated; all 105 were evaluated after extubation. For each of the 3 testing periods, patients were evaluated by using the Critical-Care Pain Observation Tool at rest, during a nociceptive procedure (positioning), and 20 minutes after the procedure, for a total of 9 assessments. Each patient’s self-report of pain was obtained while the patient was conscious and intubated and after extubation.
• Results The reliability and validity of the Critical-Care Pain Observation Tool were acceptable. Interrater reliability was supported by moderate to high weighted 
coefficients. For criterion validity, significant associations were found between the patients’ self-reports of pain and the scores on the Critical-Care Pain Observation Tool. Discriminant validity was supported by higher scores during positioning (a nociceptive procedure) versus at rest.
• Conclusions The Critical-Care Pain Observation Tool showed that no matter their level of consciousness, critically ill adult patients react to a noxious stimulus by expressing different behaviors that may be associated with pain. Therefore, the tool could be used to assess the effect of various measures for the management of pain.
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